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IRCT20160221026684N2 IRCT 2022-02-22 Yazd University of Medical Sciences The effect of Nigella Sativa on diabetic neuropathy Comparison of the efficacy of topical Nigella Sativa product and gabapentin capsule on diabetic peripheral neuropathy 2020-04-20 anticipated 120 Complete https://irct.ir/trial/45566 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random method: Simple random Random double blind Referral by a neurologist 120 envelopes: 40 pieces A (treatment), 40 pieces B (placebo), 40 pieces C (gabapentin) sealed and closed, in front of the secretary. Upon arrival, each patient is given a random envelope. The secretary only provides packages containing materials A, B and C to patients and does not know their contents, Blinding description: In this study, only the principal investigator and outcome assessor are aware of the contents of the envelope. Patients and others involved in the design have no information about the type of material in the envelopes. Drug and placebo are similar in shape, color, odor, packaging, and appearance, and blinding has been performed between them. Gabapentin capsule group is the standard treatment. 3 diabetic neuropathy. Intervention 1: First intervention group: topical Nigella Sativa product. This product is prepared from aqueous extract of black seed and base cream in the form of 10% ointment, used twice a day (morning and night before bed) and for 8 weeks on both patients' feet. The amount of ointment used each time is the size of a fingertip, which is massaged from top to bottom. The drug is formulated in Behdanebaran pharmaceutical company. Intervention 2: Control group: topical placebo- This product is prepared from a base cream and black paint in the form of an ointment, used twice a day (morning and night before bed) and for 8 weeks on both patients' feet. The amount of ointment used each time is the size of a fingertip, which is massaged from top to bottom. The placebo is formulated in Behdanebaran pharmaceutical company. Intervention 3: Second intervention group: Gabapentin 300 mg capsules- In this group, patients receive a 300 mg gabapentin capsule orally every night before bed for 8 weeks. Capsules are manufactured by JALINOUS Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: Nigella Sativa data Data on the main outcome will be made available to other researchers with the permission of the first executor. When: starting 6 months after publication To whom: people working in academic institutions Conditions: Coordinate with project analyzer Where to obtain: dr seyed ali khodaie :03537280215 dr.seyedalikhodaie@yahoo.com How to obtain: Request data from Yazd University of Medical Sciences, approval of the director of the Diabetes Research Center, approval of the first executor of the project Comments:
public seyedalikhodaie
North Shahid Sadoughi BLVD
yazd Iran (Islamic Republic of) 8917693571 +98 35 3728 0215 dr.seyedalikhodaie@yahoo.com Yazd University of Medical Sciences scientific seyedalikhodaie
North Shahid Sadoughi Blvd
yazd Iran (Islamic Republic of) 8917693571 +98 35 3728 0215 dr.seyedalikhodaie@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetes mellitus with diabetic neuropathy diagnosed by neurologist resident of Yazd controlled glucose (HbA1c less than 9) 30 years 70 years Both Spinal Disorders and Discopathy Heart disorder Renal disorder Liver disorder Active foot ulcer Autoimmune diseases mental illnesses Drug and alcohol addiction Skin diseases in the area of drug use Severe foot vascular disorders E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified Treatment - Drugs Placebo Treatment - Drugs First intervention group: topical Nigella Sativa product. This product is prepared from aqueous extract of black seed and base cream in the form of 10% ointment, used twice a day (morning and night before bed) and for 8 weeks on both patients' feet. The amount of ointment used each time is the size of a fingertip, which is massaged from top to bottom. The drug is formulated in Behdanebaran pharmaceutical company. Control group: topical placebo- This product is prepared from a base cream and black paint in the form of an ointment, used twice a day (morning and night before bed) and for 8 weeks on both patients' feet. The amount of ointment used each time is the size of a fingertip, which is massaged from top to bottom. The placebo is formulated in Behdanebaran pharmaceutical company Second intervention group: Gabapentin 300 mg capsules- In this group, patients receive a 300 mg gabapentin capsule orally every night before bed for 8 weeks. Capsules are manufactured by JALINOUS Pharmaceutical Company. Severity of peripheral neuropathy. Timepoint: before intervention and 2, 4 , 8 weeks after intervention. Method of measurement: MICHIGAN NEUROPATHY SCREENING INSTRUMENT. HbA1c. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: Chromatography (HPLC). Yazd University of Medical Sciences Approved 2019-07-30 Ethics committee of shahid sadoughi university of medical sciences Diabetes Research Center, Talar-e-Honar Alley, Shahid Sadoughi Blvd, Yazd yazd Yazd Iran (Islamic Republic of)